NCT05043610CompletedPhase 3
MSCs for Prevention of MI-induced HF
Transplantation of Mesenchymal Stem Cells for Prevention of Acute Myocardial Infarction Induced Heart Failure: a Phase III Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 4 Nov 2024
Brief summary (registry, in English)
Results from recent clinical trials on bone marrow mononuclear cell (BM-MNC) transplantation show that this intervention can help reduce the incidence of heart failure (HF) after acute myocardial infarction (AMI). However, no study has evaluated the effect of the transplantation of mesenchymal stem cells (MSCs) on a clinical endpoint such as HF. This single-blinded, randomized, multicenter trial aims to establish whether the intracoronary infusion of umbilical cord-derived Wharton's jelly MSCs (WJ-MSCs) helps prevent HF development after AMI. The study will enroll 240 patients 3 to 7 days following an AMI treated with primary percutaneous coronary intervention (PPCI). Only patients aged below 65 years with impaired LV function (LVEF \< 40%) will be included. Patients will be randomized to receive either a single intracoronary infusion of WJ-MSCs or standard care. The primary outcome of this study is the assessment of HF development during long-term follow-up (three years). Since the efficacy of MSCs is higher than BM-MNCs after AMI in the improvement of LVEF, it would be probable that these cells may have a better clinical effect as well. However, no study has evaluated the impact of the transplantation of MSCs on a clinical endpoint such as HF. This study will help determine whether or not the infusion of intracoronary WJ-MSCs in AMI patients with impaired LVEF would prevent HF development and future adverse events.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 420 (actual)
- First submitted
- 29 Aug 2021
- Start date
- 15 Sept 2021
- Primary completion date
- 1 Nov 2024
- Lead sponsor
- Shiraz University of Medical Sciences
- Diseases
- Heart failure, Coronary artery disease
- NCT number
- NCT05043610
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 420
- From 15 Sept 2021 to the primary completion date, 1 Nov 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- A history of any prior cardiac conditions (valvular, ischemic, or congenital disorders)
Other illness
- Active infection, malignancy, or autoimmune disease
Other
- Regional wall motion abnormalities outside the region of the infarction
- LV dysfunction due to other etiologies like non-ischemic cardiomyopathy, anthracycline use, or ethanol abuse (\> 6 oz./day regularly)
- Poor echocardiography window
Who the study is looking for
- Age 18-65 years
- Either gender
- First myocardial infarction in the preceding 3 to 7 days
- Post-acute myocardial infarction left ventricular ejection fraction \< 40%
- Negative pregnancy test (for women of reproductive age)
- Written informed consent
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Al-Zahra Heart Hospital, Shiraz University of Medical Sciences Coordinator of this site? Confirm its status | Shiraz | Iran | Unknown status |
| Namazee Hospital Coordinator of this site? Confirm its status | Shiraz | Iran | Unknown status |
| Faghihi Hospital Coordinator of this site? Confirm its status | Shiraz | Iran | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.